Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132392
Status:
COMPLETED
Last Update Posted:
2006-12-20
First Post:
2005-08-18
Brief Title:
ALGRX 4975 After Total Knee Replacement
Sponsor:
AlgoRx Pharmaceuticals
Organization:
AlgoRx Pharmaceuticals
Study Overview
Official Title:
A Randomized Placebo-Controlled Double-Blind Study to Evaluate the Analgesic Efficacy Safety and Tolerability of ALGRX 4975 in Subjects After Total Knee Arthroplasty
Status:
COMPLETED
Status Verified Date:
2005-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
ALGRX 4975 or placebo will be dripped onto the cut muscles and soft tissues before the end of surgery for total replacement of the knee
Each subject will undergo a screening visit a hospitalization during which total replacement of the knee will be performed and follow-up visits at 2 6 and 12 weeks after surgery In addition once discharged subjects will be contacted by telephone daily up to Day 14 Subjects will complete pain and medication diaries during the first 2 weeks following surgery and will return these diaries at the 2 week visit
Starting on the afternoon of Day 0 the day of surgery pain on active range of motion ROM of the operated knee will be measured each morning at 8 AM 2 hours and each afternoon at 3 PM 3 hours In addition if the subject ambulates pain with ambulation will be measured during the first ambulation in the morning and during the first ambulation after noon Subjects will complete the Brief Pain Inventory - Short Form BPI-SF preoperatively and at the 2 6 and 12 week visits Subjects will be questioned regarding the use of assistive devices cane walker wheelchair bedside commode or other assistive devices at screening at discharge and at the 2 6 and 12 week visits The active ROM on flexion of the knee measured using a goniometer will be recorded at screening and at the 2 week visit Sensory mapping of the knee will be performed at screening and at the 12 week visit
Each subject will undergo a screening visit a hospitalization during which total replacement of the knee will be performed and follow-up visits at 2 6 and 12 weeks after surgery In addition once discharged subjects will be contacted by telephone daily up to Day 14 Subjects will complete pain and medication diaries during the first 2 weeks following surgery and will return these diaries at the 2 week visit
Starting on the afternoon of Day 0 the day of surgery pain on active range of motion ROM of the operated knee will be measured each morning at 8 AM 2 hours and each afternoon at 3 PM 3 hours In addition if the subject ambulates pain with ambulation will be measured during the first ambulation in the morning and during the first ambulation after noon Subjects will complete the Brief Pain Inventory - Short Form BPI-SF preoperatively and at the 2 6 and 12 week visits Subjects will be questioned regarding the use of assistive devices cane walker wheelchair bedside commode or other assistive devices at screening at discharge and at the 2 6 and 12 week visits The active ROM on flexion of the knee measured using a goniometer will be recorded at screening and at the 2 week visit Sensory mapping of the knee will be performed at screening and at the 12 week visit
Detailed Description:
This is a multicenter randomized double-blind placebo-controlled study conducted in subjects undergoing unilateral TKA Subjects will undergo a screening visit up to 28 days prior to surgery A sufficient number of subjects will be enrolled to obtain at least 40 evaluable subjects Upon enrollment subjects will be randomized in a 11 ratio of ALGRX 4975 to placebo Subjects will receive a femoral nerve block prior to induction of general anesthesia Subjects will undergo total knee arthroplasty TKA under general anesthesia Prior to closure of the surgical wound a single dose of ALGRX 4975 5 mg in 60 mL or placebo will be instilled dripped by syringe over approximately 1 minute into the wound onto the cut muscles and soft tissues and allowed to dwell for 5 minutes The Investigator will then inject bupivacaine 025 up to 40 mL into the area of the wound and cut muscles and close the wound by usual surgical procedures Postoperative pain will be managed by morphine sulfate administered intravenously by patient controlled analgesia PCA Following discontinuation of the PCA pump subjects will be provided with hydrocodone 75 mgacetaminophen 500 mg for postoperative pain
Each subject will undergo a screening visit a hospitalization during which TKA will be performed and follow-up visits at 2 6 and 12 weeks after surgery Subjects will receive twice daily examinations while hospitalized for the TKA procedure In addition once discharged subjects will be contacted by telephone daily up to Day 14 to remind them to complete pain and medication diaries and then again at 4 weeks after surgery for follow-up Subjects will complete pain and medication diaries during the first 2 weeks following surgery and will return these diaries at the 2 week visit
Starting on the afternoon of Day 0 the day of surgery pain on active range of motion ROM of the operated knee will be measured using an 11 point numerical rating scale NRS each morning at 8 AM 2 hours and each afternoon at 3 PM 3 hours not within one hour after physical therapy In addition if the subject ambulates pain with ambulation will be measured during the first ambulation in the morning and during the first ambulation after noon Subjects will complete the Brief Pain Inventory - Short Form BPI-SF preoperatively and at the 2 6 and 12 week visits Subjects will be questioned regarding the use of assistive devices cane walker wheelchair bedside commode or other assistive devices at screening at discharge and at the 2 6 and 12 week visits The active ROM on flexion of the knee measured using a goniometer will be recorded at screening and at the 2 week visit Sensory mapping of the knee will be performed at screening and at the 12 week visit
Each subject will undergo a screening visit a hospitalization during which TKA will be performed and follow-up visits at 2 6 and 12 weeks after surgery Subjects will receive twice daily examinations while hospitalized for the TKA procedure In addition once discharged subjects will be contacted by telephone daily up to Day 14 to remind them to complete pain and medication diaries and then again at 4 weeks after surgery for follow-up Subjects will complete pain and medication diaries during the first 2 weeks following surgery and will return these diaries at the 2 week visit
Starting on the afternoon of Day 0 the day of surgery pain on active range of motion ROM of the operated knee will be measured using an 11 point numerical rating scale NRS each morning at 8 AM 2 hours and each afternoon at 3 PM 3 hours not within one hour after physical therapy In addition if the subject ambulates pain with ambulation will be measured during the first ambulation in the morning and during the first ambulation after noon Subjects will complete the Brief Pain Inventory - Short Form BPI-SF preoperatively and at the 2 6 and 12 week visits Subjects will be questioned regarding the use of assistive devices cane walker wheelchair bedside commode or other assistive devices at screening at discharge and at the 2 6 and 12 week visits The active ROM on flexion of the knee measured using a goniometer will be recorded at screening and at the 2 week visit Sensory mapping of the knee will be performed at screening and at the 12 week visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None